MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3O0200 - NATURA; BAG, URINARY, ILEOSTOMY

Model Number	401544
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event is considered as a consequence of lack of patient education.The reporter noted the position of the patient did not allow for free flow of urine.He noted "this was not an issue with the pouch but an issue with positioning of the tubing." the position caused urine to back up in the pouch above the one way valve.Additionally, the reporter noted the end user had a history of multiple health issues that resulted in death.Name of retailer: (b)(6).Based on the available information, this event is deemed to be a serious injury.This complaint has been evaluated.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number (b)(4).
Event or Problem Description
In response to electronic mail received from the distributor, an outbound call was made to the provided complainant.The son of end user reported that the end user deceased as of (b)(6) 2020.He stated that the end user died because of a urinary tract infection (uti) from escherichia coli (e.Coli) at age of ninety-one.The end user had urostomy secondary to bladder cancer.His father developed a lot of urinary tract infections while wearing pouch and his son felt the infections resulted in end user¿s death.He also stated that his father was never home for more than five weeks at a time due to the infections and end user was either in a hospital or in a rehab (rehabilitation).He also mentioned that he was not blaming the product but felt that there was a major issue regarding product education.He stated that it was not the pouch fault and stated in some respects it was and in some respects it was not.The end user connected to a night drainage bag at night.Near the end of his father's life, his son realized that when his father went to bed, his position in the bed resulted in the night drainage bag tubing being above the stoma and therefore because the tubing was not in a dependent position due to which the pouch did not empty causing the urine to back-up in the pouch above the one-way valve and that resulted in a urinary tract infection.This was not an issue with the pouch but an issue with the positioning of tubing.He also stated that no one told him that his father had to sleep in a chair or a hospital bed to keep the urine free flowing.He felt like he did not receive the instructions and education from the hospital or other nursing staff or product information that they should had in order to prevent the uti's.No photo is available at this time.

• Brand Name: L3O0200 - NATURA
• Common Device Name: BAG, URINARY, ILEOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal 91000 ; DR 91000
• Manufacturer (Section G): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal 91000 ; DR 91000
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 14101323
• Report Number: 9618003-2022-00293
• Device Sequence Number: 6285289
• Product Code: EXH
• UDI-Device Identifier: 00768455182787
• UDI-Public: 00768455182787
• Combination Product (Y/N): N
• Initial Reporter State: UT
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 401544
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male